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Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), [6] also known as B-lymphocyte stimulator (BLyS). [7] It is approved in the United States [8] and Canada, [9] and the European Union [5] to treat systemic lupus erythematosus and lupus nephritis. [10]
In 2005, the FDA approved the very first GLP-1 agonist to treat people with type 2 diabetes. The approval of the first GLP-1 injectable medication was a huge development and game-changer for ...
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Like Rybelsus, Ozempic injections are FDA-approved for people with type 2 diabetes. This medication is meant to be used with healthy eating habits and exercise to improve blood sugar levels.
Nonetheless, a study in 2013 reported that cSLE patients with lupus nephritis had a 19-fold higher mortality rate while aSLE patients with lupus nephritis had an 8-fold higher mortality rate than their respective age-matched populations [7] [82] and a study in 2020 suggested that the survival rate of lupus nephritis in children and adults has ...
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
AstraZeneca's Saphnelo, approved in 2021, made $280 million in 2023 sales, while GSK's Benlysta, which first gained approval in 2011, brought in 1.35 billion euros ($1.50 billion) last year.
Xeligekimab (GR1501) is a monoclonal antibody that neutralizes interleukin-17A; [1] it is being developed for plaque psoriasis, [2] axial spondyloarthritis, [3] and lupus nephritis. [4] It is in a Phase III trial in 2023.